DEVICE: HOPKINS (04048551193457)

Device Identifier (DI) Information

HOPKINS
7228CA
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551193457
GS1

1
315731430 *Terms of Use
HOPKINS® Telescope 70°, 4 mm, 15 cm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35316 Rigid optical rhinoscope
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the nasal cavity and/or nasopharynx. It is inserted into the body through a nostril or the oral cavity during rhinoscopy or an ear/nose/throat (ENT) intervention. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Also referred to as a nasoscope or nasal endoscope, it is typically used during the removal of the adenoids (glandular tissue in the nasopharynx, also known as the pharyngeal tonsils). This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EOB NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K945788 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Hydrogen Peroxide
Ethylene Oxide
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4004ae27-f7de-4fec-a4ac-a06fbf695c97
November 17, 2023
5
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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